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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K250827
Device Name aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion device with interfixation; aprevo® transforaminal lumbar interbody fusion device; aprevo® TLIF-CA Articulating System; aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X No Cams
Applicant
Carlsmed, Inc.
1800 Aston Ave. Suite 100
Carlsbad,  CA  92008
Applicant Contact Julie Lamothe
Correspondent
Karen Liu Consulting
3268 Governor Dr. #129
Carlsbad,  CA  92122
Correspondent Contact Karen Liu
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
ODP   OVD   OVE  
Date Received03/18/2025
Decision Date 07/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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